Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level II
Prevailing Wage:82534
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2022-11-01
Prevailing Wage Expiration Date :2023-06-30
Wage Offer From:95000
Wage Offer To:105000
Wage Offer Unit of Pay:Year
Workstie Address Line 1:3200 Lakeside Drive
Worksite Address Line 2:
Worksite City :Santa Clara
Worksite State:CALIFORNIA
Worksite Postal Code:95054
Job Title:Regulatory Affairs Specialist
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Biomedical Engineering
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:Y
Accept Alternate Major:See H.14.
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:36
Accept Alternate Job Title:Medical Product Manager, Regulatory Affairs Associate, or related
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Bachelors or foreign equivalent degree in Biomedical Engineering, PharmacyPharmacology, BiochemistryImmunobiology, Regulatory AffairsScience or in a closely related regulatory affairs, quality, or biological science field with at least 3 years of experience in i ensuring and coordinating compliance with quality management system regulatory requirements for medical devices throughout product lifecycle, including ISO 13485, FDA 21 CFR 820, EU MDD, and equivalent local regulations for medical devices; ii providing regulatory representation and support for quality management system and product lifecycle change management; iii preparing, submitting, and maintaining domestic and international technical files, product registrations and licensing applications for Class II or higher medical devices; and iv understanding, investigating, and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval, and determining trade issues to anticipate regulatory obstacles.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2022-11-01
Job Oder End Date:2022-12-01
Sunday Edition Newspaper:Y
First Newspaper Name:San Francisco Chronicle
First Advertisement Start Date:2022-11-06
Second Newspaper Name:San Francisco Chronicle
Second Advertisement Type:Newspaper
Second Ad Start Date:2022-11-20
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2022-11-03
Job Search Website to Date:2022-11-18
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2022-11-28
Employee Referral Program to Date:2022-12-12
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2022-11-09
Local Ethnic Newspaper to Date:2022-11-15
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:TAIWAN
Foreign Worker Birth Country:TAIWAN
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:BIOMEDICAL ENGINEERING
Year of Compelted Education:2019
Foreign Worker Istitution of Eduation:THE GEORGE WASHINGTON UNIVERSITY
Foreign Worker Education Instution Address Line 1:2121 I STREET NW
Foreign Worker Education Institution Address Line 2: